坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.5对照品水分(%)0.14对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.261936431938301934961933541933461935340.11
2 16.171934891931171933030.14
单位质量响应值RSD%判断
11902.4611954.420.31数据可信
供试品溶液-1批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16765-67653.2023.5620.253.203.5620.26
26272-62722.9682.97
310396-103964.9204.92
46559-65593.1043.10
57917-79173.7473.75
67198-71983.4073.41
10min138341-3834118.14520.1712.4518.1820.2112.46
237445-3744517.72117.75
348804-4880423.09723.15
438151-3815118.05518.09
548422-4842222.91622.96
644517-4451721.06821.11
15min179302-7930237.53040.3411.1337.7740.6011.14
274870-7487035.43335.66
391873-9187343.48043.79
476765-7676536.33036.56
597955-9795546.35846.65
690636-9063642.89443.17
20min1115001-11500154.42557.288.4155.0857.998.44
2108822-10882251.50152.12
3129162-12916261.12761.92
4112722-11272253.34753.99
5133925-13392563.38164.19
6126511-12651159.87260.62
30min1153198-15319872.50275.974.6673.7677.324.73
2151654-15165471.77272.97
3161323-16132376.34777.82
4159304-15930475.39276.62
5170760-17076080.81482.33
6166883-16688378.97980.39
45min1181778-18177886.02888.012.6088.0990.202.72
2179606-17960685.00086.99
3192460-19246091.08393.41
4184747-18474787.43389.50
5189377-18937789.62492.04
6187828-18782888.89191.18
60min1186872-18687288.43990.773.1291.4693.943.20
2185260-18526087.67690.61
3200547-20054794.91198.24
4190309-19030990.06593.11
5197379-19737993.41196.82
6190476-19047690.14493.42
极限1188754-18875489.32990.511.3093.3394.681.41
2190212-19021290.01993.93
3195524-19552492.53396.92
4190532-19053290.17194.21
5192693-19269391.19495.64
6189738-18973889.79594.08
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.5对照品水分(%)0.14对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.261935961933471934351935321935381934900.06
2 16.171937881938541938210.03
单位质量响应值RSD%判断
11899.7511986.460.52数据可信
供试品溶液-2批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124015-2401511.35111.766.3811.3511.766.40
223942-2394211.31711.32
323063-2306310.90110.90
426542-2654212.54612.55
527072-2707212.79612.80
624609-2460911.63211.63
10min174849-7484935.38034.006.2335.5134.136.22
276205-7620536.02136.15
363807-6380730.16030.28
470538-7053833.34233.48
574278-7427835.11035.25
671842-7184233.95834.09
15min1113858-11385853.81952.665.2754.3453.175.27
2115475-11547554.58355.11
3100226-10022647.37547.83
4109606-10960651.80952.32
5114428-11442854.08854.62
6114877-11487754.30054.81
20min1140749-14074966.52966.003.7067.6567.103.72
2142668-14266867.43768.57
3130348-13034861.61362.60
4137350-13735064.92366.01
5141908-14190867.07768.21
6144750-14475068.42169.53
30min1168300-16830079.55280.121.5681.4181.951.59
2168989-16898979.87881.76
3165416-16541678.18979.86
4172359-17235981.47183.28
5169640-16964080.18682.06
6172348-17234881.46683.34
45min1183102-18310286.54987.902.3489.2990.622.24
2182137-18213786.09388.86
3186643-18664388.22390.76
4194038-19403891.71894.43
5183602-18360286.78589.55
6186263-18626388.04390.82
60min1188667-18866789.17989.982.8192.8893.682.70
2185848-18584887.84791.57
3190820-19082090.19793.71
4200745-20074594.88898.62
5187389-18738988.57592.31
6188754-18875489.22192.97
极限1190246-19024689.92690.023.8894.6294.723.73
2184484-18448487.20291.90
3187285-18728588.52693.04
4204994-20499496.897101.68
5188729-18872989.20993.93
6186992-18699288.38893.13
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.5对照品水分(%)0.14对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.261940031940011940761939421940001940040.03
2 16.171945671949301947480.14
单位质量响应值RSD%判断
11931.3712043.780.67数据可信
供试品溶液-4批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116148-161487.6058.9012.127.608.9012.13
219326-193269.1019.10
321370-2137010.06410.06
415989-159897.5307.53
520429-204299.6219.62
620144-201449.4869.49
10min151285-5128524.15226.335.0524.2426.435.06
258252-5825227.43327.53
357919-5791927.27627.39
454134-5413425.49325.58
558273-5827327.44327.55
655644-5564426.20526.31
15min188238-8823841.55444.806.7241.9145.196.70
298826-9882646.54046.95
3102590-10259048.31348.73
493805-9380544.17644.54
5100019-10001947.10247.51
687281-8728141.10341.50
20min1123900-12390058.34858.003.9759.1658.893.93
2125524-12552459.11360.04
3119501-11950156.27757.23
4123919-12391958.35759.22
5130103-13010361.27062.20
6116029-11602954.64255.50
30min1158509-15850974.64776.483.9076.1178.013.87
2165032-16503277.71979.30
3156176-15617673.54875.13
4167230-16723078.75480.26
5171206-17120680.62682.24
6156236-15623673.57775.04
45min1179850-17985084.69786.002.5786.9988.392.53
2181477-18147785.46387.91
3178760-17876084.18486.58
4191391-19139190.13292.51
5184154-18415486.72489.24
6180097-18009784.81387.09
60min1185829-18582987.51388.083.6390.7591.423.55
2180409-18040984.96088.35
3186368-18636887.76791.10
4198521-19852193.49096.87
5190404-19040489.66793.14
6180644-18064485.07188.29
极限1181759-18175985.59687.862.7489.8092.182.70
2183176-18317686.26390.60
3185840-18584087.51891.82
4195788-19578892.20396.62
5188651-18865188.84293.31
6184220-18422086.75590.92
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.5对照品水分(%)0.14对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.261943631941231942431939101940711941420.09
2 16.171962781965291964040.10
单位质量响应值RSD%判断
11939.8512146.201.22数据可信
供试品溶液-24110402批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118031-180318.4538.6310.508.458.6310.51
217908-179088.3958.40
316478-164787.7257.72
416920-169207.9327.93
521782-2178210.21110.21
619387-193879.0889.09
10min153485-5348525.07325.409.8125.1725.509.81
251595-5159524.18724.28
349683-4968323.29123.38
449723-4972323.31023.40
563390-6339029.71629.83
657208-5720826.81826.92
15min189967-8996742.17542.915.9942.5543.296.02
288229-8822941.36141.72
388725-8872541.59341.94
486584-8658440.59040.94
5101343-10134347.50847.95
694406-9440644.25644.66
20min1127031-12703159.55159.896.8560.3960.746.87
2123162-12316257.73758.56
3123369-12336957.83458.64
4118447-11844755.52756.32
5143356-14335667.20468.18
6131155-13115561.48462.37
30min1167634-16763478.58578.341.6180.0979.861.70
2163277-16327776.54278.01
3166363-16636377.98979.44
4166020-16602077.82879.24
5171429-17142980.36482.08
6167965-16796578.74080.31
45min1192914-19291490.43690.600.9992.8192.990.95
2190096-19009689.11591.43
3194855-19485591.34693.66
4195119-19511991.46993.75
5192283-19228390.14092.75
6194339-19433991.10493.55
60min1201802-20180294.60294.651.4297.9898.051.31
2201554-20155494.48697.79
3199484-19948493.51696.85
4206720-20672096.908100.20
5198767-19876793.18096.79
6203133-20313395.22698.69
极限1199592-19959293.56695.742.8598.00100.192.73
2199673-19967393.60497.96
3200950-20095094.20398.57
4213692-213692100.176104.55
5202443-20244394.90399.55
6209023-20902397.987102.51
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